Medical Device Regulatory Affairs Strategist

Overview

In an era marked by rapid advancements in technology and evolving healthcare regulations, global healthcare organizations require regulatory leaders well-versed in the diverse public and private factors shaping the industry. Oracle is seeking skilled regulatory affairs specialists in the medical technology domain to bolster its healthcare and life sciences divisions' success.

Role Summary

This position primarily supports Oracle's Health & Life Sciences units, collaborating extensively with other business segments offering products to these industries. The ideal candidate thrives in a dynamic software development setting and keeps abreast of shifting regulatory environments. We are looking for a strategic regulatory professional who fosters collaboration, innovates solutions, and is committed to delivering high-quality results.

Key Responsibilities

• Partner with product engineering teams to evaluate product features and formulate regulatory strategies for Middle East and African markets.
• Coordinate with multiple teams to prepare and manage submissions to health authorities such as SFDA (Saudi Arabia), MOHAP (UAE), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt), and PPB (Kenya), ensuring continuous compliance.
• Maintain up-to-date regulatory records, technical documentation, and oversee post-market surveillance to ensure adherence to relevant regulations.
• Assist in internal and external audits by identifying risks and gaps, and implementing corrective actions.
• Provide subject matter expertise regarding standards, regulations, and quality management system utilization to internal clients.
• Lead regulatory and compliance projects related to health products.
• Review and advise on labeling, marketing collateral, clinical protocols, design workflows, and procedures to uphold regulatory and quality standards.
• Stay informed on regulatory changes affecting global markets and align company practices accordingly.
• Develop and sustain productive relationships with regulatory bodies, affiliates, and cross-functional teams to ensure coherent regulatory strategies and outcomes.

Additional Duties

• Evaluate internal processes, controls, communication, and documentation relevant to regulatory compliance, recommending improvements.
• Guide internal and external audit processes to identify and rectify compliance risks and shortcomings.
• Compile and prepare comprehensive regulatory submission packages and audit materials.
• Serve as liaison for designated regulatory matters with health authorities.
• Support the creation of robust risk management, quality management, and regulatory oversight programs tailored to product and service design, aligned with Oracle's security and quality standards.
• Develop and deliver training related to industry regulatory requirements for global business units, including cloud and operational teams.
• Conduct risk assessments and develop strategies to mitigate identified business risks.
• Identify and integrate relevant industry regulations and contractual obligations into organizational processes and standards.
• Manage certifications by coordinating with vendors for standards such as PCI, HIPAA, HITECH, ISO, and SOC2.
• Create security documentation for customers and internal stakeholders that highlight security as a competitive advantage.
• Develop management metrics and reporting related to regulatory risk management activities.
• Implement vendor security and quality management programs.

Preferred Qualifications

• A Bachelor’s degree in pharmacy, biology, biomedical engineering, engineering, life sciences, health sciences or a related discipline.
• Experience with Software as a Medical Device (SaMD) in regulatory affairs, quality compliance, or product development within the medical device sector; proven track record managing submissions in Middle East and Africa is essential.
• In-depth understanding of regulatory frameworks across the Middle East and African markets, with demonstrated skills in interpreting local legislation, supporting market entry, lifecycle compliance, and regulatory engagement.
• Strong analytical, organizational, and planning skills with the capability to handle multiple priorities independently in a fast-moving multicultural environment.
• Familiarity with quality management systems, notably ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR parts 1000/1001.
• Experience with continuous improvement methodologies and risk management practices complemented by excellent communication abilities.
• Involvement with regional trade bodies, industry groups, or regulatory forums is advantageous.
• Adaptability to shifting priorities within a dynamic business context and capacity to perform under evolving conditions.

About Oracle

Oracle integrates data, infrastructure, applications, and expertise to drive innovations impacting billions globally, embedding AI across its solutions to foster a better future. The company values diversity and inclusion, offers flexible benefits including medical, life insurance, and retirement plans, and actively supports community volunteering. Oracle is an equal opportunity employer and complies with all relevant employment laws.

Accessibility

Oracle is dedicated to ensuring accessibility for applicants with disabilities throughout the employment process. Those needing accommodations can contact the company directly.